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Oracle Argus Interchange Japanese User's Guide Release 7.0.3 E40572-01 |
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# 2 Configuring Argus Interchange

This section is intended for Argus Interchange Administrators. The flowchart shows the steps to follow when configuring, reviewing, and administering Argus Interchange.

## Argus Interchange Mapping Utility

The Argus Interchange Mapping Utility enables you to store multiple profiles. This enables companies to transmit E2B reports to multiple agencies. The Argus Interchange Mapping Utility maintains an audit log that tracks every change made to the settings. You can also use this utility to view Trading Partner Configurations. This chapter includes discussions of the following:

- Logging On and Off Interchange

- Viewing Regulatory Authorities/Trading Partners

- Configuring Argus Interchange Service

- Adding a Database for Argus Interchange Service

- Viewing the Audit Log

- Comparing DTD Profiles

- E2B Codes Translation

- E2B Extensions

### Logging On and Off Interchange

This section provides information about a logging in and out of Interchange.

#### Logging On to Interchange

To log on to Interchange:

1. Go to Start-->Programs-->Oracle-->ESM Mapping.

2. Enter the User Name, Password, and Database in the log on dialog.

   Note: The User Name and Password for the Argus Interchange Mapping Utility are created through User Configuration in the Web Console. This is done by enabling the ESM Admin checkbox for the user.

3. Click Login.

#### Exiting from Interchange

To exit from the Argus Interchange Mapping Utility:

1. Select Administrator -> Exit to open a confirmation dialog.

2. Click Yes to exit Argus Interchange Mapping Utility.

### Working with Profiles

This section provides information about working with profiles and includes discussions of the following:

- Defining a Profile

- Printing a Profile

- Copying a Profile

- Deleting a Profile

#### Defining a Profile

This section describes how to view or modify the rules of a DTD profile in Argus Interchange Mapping Utility. You can view profile details by selecting a Profile from the Argus Interchange Mapping Utility window.

The following table lists and describes items that are common to each tab of the Argus Interchange Mapping Utility.

##### Using the Transmit Tab

The following is an illustration of the Transmit tab.

To view details in the Transmit Tab:

1. Select a profile from the Profile drop-down list.

2. Click Transmit.

The following tables lists and describes the items on the Transmit tab:

Item | Description
--- | ---
Adverse Event Database Select Statement | Enables you to enter and view the SQL logic used to extract the value of the selected element of the DTD profile from AE database.
E2B Check checkbox | Indicates whether the selected profile is used in the E2B check functionality in Argus. The E2B check function is used to validate E2B reports based on the validation rules defined for the DTD profiles. Only the profiles that have the E2B check selected are used for validation.

#### Printing a Profile

This section describes how to setup your printer and print the profile.

##### Setting Up the Printer

You should set up your printer before printing a profile.

To set up your printer

1. Select Administrator -> Printer Setup to open the Printer Setup dialog box.

2. Select the default printer from this dialog box.

The following is an illustration of the Print dialog box.

##### Printing a Profile

Use the following procedure to print a profile.

1. Select Administrator -> Print Profile.

2. This prints the selected profile to your default printer.

The following is an illustration of a printed profile.

#### Copying a Profile

Note: The Copy Profile option can be used to create custom E2B profiles with customized Export / Import mapping logic for any E2B element. However, any new changes / fixes applied to factory E2B profiles are not automatically applied on the custom E2B profiles. Hence, the custom profile logic may get obsolete by any Argus Safety version upgrade which has changes / fixes applied to factory E2B profiles. In such a scenario, customers should re-create their custom E2B profile again, by copying the new factory E2B profile and applying their custom Export / Import mapping logic manually.

Use the following procedure to copy a profile.

1. In the Profile list, select the profile to copy.

2. Select Administrator -> Copy Profile, to open the Copy Profile dialog box.

3. Type the profile name in the To Profile field, click Save, and click OK.

#### Deleting a Profile

You can only delete profiles created or modified in the Interchange Mapping Utility interface. You cannot delete the pre-installed Argus Interchange profiles.

To delete a profile

1. Select the profile to delete from the Profile list.

2. Select Administrator -> Delete Profile.

3. Click Yes to confirm the deletion of the profile.

### Viewing Regulatory Authorities/Trading Partners

Use the following procedure to view regulatory authorities/trading partners.

1. Select Administrator->Trading Partners to open the Agency List dialog box.

2. Double-click the required Regulatory Authority or Trading Partner to view its details.

3. The system opens the Trading Partner Configuration dialog box. You cannot modify the information in the dialog box.

   Note: To modify or create new Regulatory Authorities/Trading Partners, choose Reporting Destination in the Code List in Argus Console.

### Configuring Argus Interchange Service

You can configure the Argus Interchange Service by updating the initialization (INI) file from the Argus Interchange Mapping interface.

To configure Argus Interchange Service:

1. Select Administrator -> Setup INI File menu in the Interchange Mapping Utility to open the Service INI File Setup dialog box.

2. Use the items in the Service INI File Setup dialog to configure the Argus Interchange Service INI file.

3. Enter the data for each field as required.

#### Service INI File Setup Dialog Box

The following tables lists and describes the fields in the Service INI File Setup dialog box.

Item | Description
--- | ---
IT E-mail | Enter the e-mail address that Argus Interchange Service should use to send e-mails, if the transmit time out occurs for Physical Media or EDI Gateway.
Business E-mail | Enter the e-mail address that Argus Interchange Service should use to send e-mails, if the Receive ACK time-out value is reached.
User E-mail | Enter the e-mail address that Argus Interchange Service should use to send e-mails, when the user does not process the E2B Report within the time-out value. The Argus Interchange Service uses SMTP as its mail system.
Sender E-mail | Enter the e-mail address that Argus Interchange Service should display, as the 'From' address in the e-mails that it sends.
EDI Software Name | Enter the EDI software name (i.e., Cyclone).
EDI Database Name | Enter the database name for the EDI software.
EDI User ID | Enter the user name for EDI database.
EDI Password | Enter the password for the user name associated with the EDI database.
EDI Client Software | Enter the type of database used by the EDI software. Only Oracle databases are certified to be integrated with Cyclone.
DTD Path | Enter the path for the DTD file.
Log File Path | Enter the path where the Argus Interchange Service will write the log files.
Multiple Database Section | Displays all the configured databases for ESM Service.
Delete Button | Click Delete to remove the entire Database Configuration from ESM Service INI File.

### Adding a Database for Argus Interchange Service

You can configure the Argus Interchange Service to support multiple database.

To configure a database:

1. In the Setup INI File dialog box, double click Add New Process to open the Service DB Setup dialog.

2. Use the items in the Service DB Setup dialog to configure the ESM Service INI file.

3. Enter the data in the fields as required.

   Note: ESM Service.ini can be configured for MAX_FILES_IMPORT_PER_RUN at database level under the Database section. This should be set to a number. This determines how many files are read from incoming folder so as to allocate to Receive Process(es). This includes both ICSR reports and Acknowledgments. If it is not defined, an internal limit of 1000 is assumed.

#### Service DB Setup Fields

The following table lists and describes the fields in the Service DB Setup dialog box.

Item | Description
--- | ---
Database Name | Enter the name of the Adverse Event database.
Unique Database ID | Identifies each database uniquely. In the case of multiple databases, the value of this field should be unique.
User ID | Enter the user name for the Service.
Password | Enter the password associated with the User Name entered in the USER ID field.
Process | Enter the full path of the ESMProc.exe file. The system uses this path to locate the ESMProc.exe file.
Receive Process | Enter the full path of the E2BReceive.exe file. The system uses this to locate the E2BReceive.exe file.
Archive Folder | Enter the full path where the system places the file processed by Argus Interchange.
Receive Processes Count | Enables you to specify multiple E2B receive processes You can specify from 1 to 5 E2B receive processes The default is 1.
Process Elapse Time | Enter the time interval for the Argus Interchange Process to run.
Enter EDI Transmit Time out Value | The amount of time, in minutes, that must pass before the system sends an e-mail message when an E2B Report has not been transmitted within a specified time period. Note: The minimum value for the time-out is 10 minutes.
Enter Physical Media Transmit Time out Value | Enter amount of time, in minutes, that must pass before the system can send an e-mail message when an E2B Report has not been sent manually by a specified person within a specified time period. Note: The minimum value for the time-out is 10 minutes.
Enter Receive ACK Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an ACK message has not been received within a specified time period. Note: The minimum value for the time-out is 10 minutes.
Enter Processing Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an Incoming Report has not been processed within a specified time period. Note: The minimum value for the time-out is 10 minutes.
Enter XML Transmit Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when an XML file is not picked up by the Gateway. Note: The minimum value for the time-out is 10 minutes.
Enter Binary Transmit Time Out Value | Enter the amount of time, in minutes, that must pass before the system can send an e-mail message when a binary file is not picked up by the Gateway. Note: The minimum value for the time-out is 10 minutes.
Enter MDN Time Out Value | Enter the amount of time, in hours, that must pass before the system stops polling the MDN information from the EDI server after receiving the Business ACK for a transmitted report.
Enterprise Short Name | Select the relevant enterprise short name, from the alphabetically-sorted list, containing all the enterprise short names. When an enterprise is selected, it loads the list of agencies for that enterprise in the Agency Name drop-down list.
Agency Name | Select the Agency from the drop-down list. This list contains all the agencies of the enterprise which had been selected in the Enterprise Short Name drop-down list. Note: If you change an agency name and also change the Incoming/Outgoing folders for the agency, the application prompts you to save the changes made.
Local Company | The system automatically populates this field when Agency is selected.
Incoming Folder | Enter the path to the folder where incoming files are stored.
Outgoing Folder | Enter the path to the folder where outgoing files are stored.
E2B Attachment Outgoing Folder | Enter the path to the folder where outgoing E2B attachments are processed.
Save Button | Click Save to set the Folder Paths configured for the Agency as Default. When selecting another agency to configure from the Drop Down, all the Paths will remain.
Delete Button | Click Delete to delete the entire configuration for the Agency selected only.

Note: Existing customers upgrading to the 7.0 release must ensure that all E2B transmissions have completed their cycles before being upgraded to 7.0. The existing customer should manually specify the incoming/outgoing folder configuration in Argus Interchange Mapping Utility for all the agencies, based on the folders configured in the ESMService.ini of the customer's previous application version.

### Viewing the Audit Log

The audit log stores changes made to the system from the application in the audit log. You can also view and filter individual changes.

To view the audit log:

1. Select Administrator -> Audit Log.

2. When the system opens the Audit Log dialog box, enter the appropriate data in each field and click Search.

3. When the system displays the search results, double-click a row to view detailed information about the changes made in the Audit Log Detail dialog box.

4. Select an item in the list at the bottom of the Audit Log Details dialog to view details of the old value and the new value of the selected item.

#### Audit Log Dialog Box Fields

The following table lists and describes the fields in the Audit Log dialog box.

Item | Description
--- | ---
From | Enter the search start date.
To | Enter the search end date.
Range | Select a pre-configured date range on for the search. Note: When the Argus Interchange Audit log is invoked, it shows the default range of the last 7 days.
User's List | Select a user from the list of users.
Print Log | Prints the current view.
Search | Performs the search.
Close | Closes the dialog.

### Comparing DTD Profiles

You can compare two DTD profiles to find element-level differences. Select a source profile in the left pane and a target profile in right pane and run the Compare Profiles utility to generate the differences. The Compare Profiles utility also enables you to update the SQL statements (at the element level) of the Destination Profile elements with those of the Source Profile.

To compare DTD profiles:

1. On the Argus Interchange Mapping Utility menu bar, click Administrator -> Compare Profiles.

2. When the system opens the Compare Profiles dialog box, use the items in the Compare Profiles dialog to compare profiles.

3. Enter the data in the files as required.

#### Compare Profile Dialog Box Fields

The following table lists and describes the fields in the Compare Profile dialog box.

Item | Description
--- | ---
Source Profile drop-down | Is used for selecting a source profile from the available profiles configured in the system.
Destination Profile drop-down | Displays the profiles with the same DTD version and type (message/acknowledgement) as the ones in the Source profile. Note: The source profile is to be selected before selecting the destination profile. The destination profile is disabled if you have not selected the source profile.
Show Difference Only | Displays those nodes that contain different SQL statements between the source and destination profiles when this checkbox is checked.
Compare | Compares the differences between the source and destination profiles when this button is clicked. Note: The elements that are different in the Source and Destination profiles are displayed in a light gray background color.
Source Profile pane | Displays the source profile and its elements in a tree structure. When you click on any of the elements, the corresponding SQL statements are displayed on the source profile textbox, which is on the left-corner below the Source Profile pane.
Destination Profile pane | Displays the destination profile and its elements in a tree structure. When you click on any of the elements, the corresponding SQL statements will be displayed on the Destination profile textbox, which is on the right-corner below the Destination Profile pane.
Print | Prints all the SQL statements of the source and the destination profile with differences highlighted. Note: If there are no differences between the source and destination profiles, the following pop-up message is displayed: "No differences found' and no report shall be printed."
Update | Updates the individual SQL statements related to each element. Clicking the Update button also updates SQL statements in the destination profile. Note: The Update button is enabled when the nodes with different SQL statements are clicked.
Update All | Updates all the differences in SQL statements across all the elements between the source and destination profiles. Note: When a user clicks the Update All button, the following pop-up message is displayed: "Are you sure you want to update all the SQL statements in Destination Profile with Source Profile?" Clicking Yes updates all the SQL statements whereas clicking No does not update.
Close | Closes the Compare Profiles window.

Note: The Update and Update All buttons are never enabled when the profile selected from the Destination Profile is of the type template.

### E2B Codes Translation

E2B Codes Translation enables you to configure rules to translate the E2B codes and values in the incoming E2B reports, which come from different trading partners to preferred values in the AE system during case creation.

In the Interchange Mapping Utility, click Administrator -> E2B Translation Codes to open the E2B Code Translation screen.

#### E2B Codes Translation Fields

The following table lists and describes the fields on the E2B Codes Translation screen.

Item | Description
--- | ---
Agency Name | Enables the user to select an agency name from the drop-down list box.
# | Displays the serial number.
DTD Element Name | Displays the DTD element name.
Input Value | Displays the type of input value
Output Value | Displays the type of output value.
Edit | Enables you to edit the information

#### Configuring E2B Codes Translation

Use the following procedure to configure E2B Codes Translation.

1. Select the Agency Name from the drop-down list box to displays the DTD Elements and their descriptions.

2. Click Edit to edit the DTD Element Name, Input Value, Output Value, and DTD Element Description.

3. Click Save to save your changes.

### E2B Extensions

You can use the existing reporting destination configuration to choose an extended E2B profile. The system uses the agency and company identifier to identify the profile to use and sends the information in the following XML elements:

`<messagesenderidentifier>Company X</messagesenderidentifier>`

`<messagereceiveridentifier>Agency Y</messagereceiveridentifier>`

The Interchange mapping utility also supports the defined extended E2B elements as follows:

- A switch in the Interchange mapping tool identifies a profile as either a standard profile or an extended E2B profile but only for the Receive tab. The additional fields are formatted as follows:

  <XXX>_EXTENSION []

  where:

  XXX is the tag name followed by _EXTENSION to indicate that this is an extended E2B tag element

  When using this switch:

  - Do not enter any blank spaces or underscore characters ( _ ) in the XXX naming convention.

  - In the extended E2B tags, the element number in the brackets ( [ ] ) is always empty. For example, Patient Ethnicity, Event Hospitalized Start Date / Stop Date.

  - This switch is enabled only for profiles copied from the Factory profiles (default unchecked). This flag is disabled for all factory profiles.

  - During configuration, GPS updates the DTD profile with this information before it adds any additional E2B elements.

  - The system maps extended E2B fields are mapped to existing Argus fields or to user-defined fields, as appropriate. For example, the system maps the following extended E2B fields to the following Argus tables.

    E2B + Field | Argus Case Form UI Field Name | Argus Field Label Description
    --- | --- | ---
    patientethnicity_extension | PATIENT | Patient Ethnicity | Patient Ethnicity
    reactionintensity_extension | EVENTS | Event Intensity | Event Intensity
    reactionhospstartdateformat_extension | Argus Date entry format YYYYMMDD or YYYYMM or YYYY | Hospitalized Start Date Format
    reactionhospstartdate_extension | EVENTS | Hospitalized Start Date | Hospitalized Start Date
    reactionhospstopdateformat_extension | Argus Date entry format YYYYMMDD or YYYYMM or YYYY | Hospitalized Stop Date Format
    reactionhospstopdate_extension | EVENTS | Hospitalized Stop Date | Hospitalized Stop Date

  - The system sends an acknowledgement if the message import is successful and a rejection if the message import is not successful.

You can view the extended elements for the following:

- E2B Viewer

  - No updates to the CIOMS / MedWatch Reports

  - The Decoded View / SGML View displays the additional elements added as a part of the Extended E2B

- E2B Difference Report

  - When imported, the system displays the additional fields in the current difference report viewer.

- E2B Selective Intake for Initial and Follow up E2B Reports

  - You can selectively import the additional fields the system adds to the Extended E2B in the Argus case.

  - The PDF reports display the additional fields added to the Extended E2B.

- The E2B Warnings/Errors display the warnings/errors if warnings or errors defined for the fields added to the Extended E2B.

## Web Console

The Web Console enables you to configure the Regulatory Authorities to which E2B Reports need to be submitted. In accordance with ICH Guidelines, you can configure additional Code List items with new E2B codes.

This section includes discussions of the following:

- Configuring Regulatory Authorities

- Configuring SMTP

- Configuring Code List Items

### Configuring Regulatory Authorities

Transmitting E2B reports to an Agency/Trading Partner, requires you to create a regulatory authority entry in the Code List. After creating the regulatory authority, you can transmit regulatory reports to it.

To configure a regulatory authority:

1. On the Argus Console, Click Code Lists -> Argus.

2. When the system opens the Code List Maintenance screen, select Reporting Destination from the list.

   Note: If a report has already been generated for a Regulatory Authority, the system disables the Delete button in the Code List dialog box for the particular Regulatory Authority. However, it is still possible to modify these reports there.

   Refer to the Argus Safety Guide for information on using the first three tabs of the Reporting Destination.

3. Click the EDI tab, select the appropriate data for each item, and enter the data in the fields as required.

#### EDI Tab Fields

The following table lists and describes the fields on the EDI tab.

For Argus J users, an additional field called "Message Profile 2" shows up for the configuration of the PMDA - J profile. This field is required for PMDA agency to specify PMDA J profile.

Field | Purpose
--- | ---
SGML/XML | Enables you to select whether to send the report in SGML or XML format.
Mark as Auto Submit | Enables you to mark the report for auto submission.
Imported Cases are assigned to | Enables you to select the country where imported cases need to be assigned. Note: This list contains the configured Argus sites. The default value is the site of the importing user.
Initial Workflow State | Enables you to configure the initial workflow state for the case. Note: This list contains Argus workflow states. The default value is blank. If you select blank as the workflow state, the system treats the case as a new case being booked-in.
Agency Identifier | Enables you to enter the routing ID configured in Cyclone for the sender community.
Identification Code | Enables you to enter the agency Duns code, a unique code that identifies a trading partner.
Code Qualifier | Enables you to enter the code qualifier. The system uses the code qualifier to interpret the identification code.
XML Source Classification | Defines the E2B source file classification during the E2B import. The system populates this drop-down from the Attachment Classification code list.
Selection Source Classification | Defines the classification of the PDF for initial intake or the difference report during E2B import. The system populates this drop-down from the Attachment Classification code list.
Message Profile | Enables you to select a message profile.
Message Profile 2 | Enables you to select a message profile for J elements. This profile is enabled for J users.
ACK Profile | Enables you to select the acknowledgement profile.
Primary Receive Agency | Indicates that this is the primary agency receiving E2B reports.
Auto Accept ICSR's | Enables or disables the auto-accept E2Bs for the agency.
Transmit E2B Attachments | Enables or disables transmission of E2B attachments for the agency.
Use Japanese Aware Date for Reporting | Check this checkbox to use Japanese Aware Date for reporting.
Allow multiple reports for Marketed Drugs | Check this checkbox to allow multiple reports for Marketed Drugs.
Allow multiple reports for Investigational Drugs | Check this checkbox to allow multiple reports for Investigational Drugs.
Identification Code | Enables you to enter the company Duns code, a unique code that identifies a trading partner.
Company Identifier | Enables you to enter the company identifier.
Code Qualifier | Enables you to enter the code qualifier. The code qualifier is used to interpret the identification code.
File Name | Enables you to enter the file name
SGML Declaration File | Enables you to enter the SGML Declaration File.
Maximum # of reports to include in the msg | Enables you to enter the maximum number of reports that will be transmitted in one message.
Method | Enables you to select a method. This field contains E2B-EDI Gateway, E2B Physical Media, and E2B-XML Transmission values.
EDI Header Required | Enables you to generate the required EDI Header.
XML Version | Enables you to enter the XML Version.
URL of Message DTD | Enables you to enter the path where the message DTD resides on the Internet or to enter the full path, if it is located on the disk.
Encoding | Enables you to select the character set encoding used in XML
Use Japanese Aware Date for Reporting | Enables you to ensure that reporting is based on the Japanese Aware Date. If this checkbox is not checked, reporting is based on the English Aware Date.
Allow multiple reports for Marketed Drugs | Checking this checkbox allows the system to schedule multiple reports for marketed drugs.
Allow multiple reports for Investigational Drugs | Checking this checkbox allows the system to schedule multiple reports for investigational drugs.
URL of ACK DTD | Enables you to enter the path where the ACK DTD resides on the Internet or enter the full path, if it is located on the disk.

Note: In the File Name field, be sure to enter the appropriate naming convention followed by "####" before the transmission extension.

### Configuring SMTP

Argus Interchange Mapping Utility can be configured to send emails to notify the appropriate people on the occurrence of some incidents or errors while processing E2B reports. These emails are sent using Argus Safety Service. You can use Argus Console if you need to configure these emails to be sent using SMTP.

To enable Argus Safety Service to use the SMTP protocol to send e-mail to the e-mail server, use the SMTP Configuration Utility in the following way.

To configure SMTP:

1. Open Argus Console.

2. When the system opens the Code List Maintenance screen, click System Configuration -> SMTP Configuration.

3. When the system opens the SMTP Configuration dialog box, enter the appropriate data in each field.

#### SMTP Configuration Dialog Box Fields

The following tables lists and describes the fields in the SMTP Configuration dialog box.

Item | Description
Server IP or Name | The SMTP server IP address or name.
Port | The port number. The default port number is 25.
Authentication | The authentication type to use. Basic Authentication -- The user must enter a user name and password in the Username and Password fields. No Authentication -- The Username and Password fields are disabled. NTLM Authentication, the authentication of the OS user logged into the system is automatically passed. Additionally, the Username and Password fields are disabled in this authentication.
SMTP Username | The SMTP username.
SMTP Password | The SMTP password.
Enable SMTP? | Select this check box to ensure that AG Service uses SMTP to send e-mail.

### Configuring Code List Items

Argus Safety is currently shipped with E2B Codes for the applicable factory data items. If you enter new items, E2B codes must be derived from ICH guidelines and entered as described here.

Note: From Argus Console, click Code Lists -> Argus to open the Code List Maintenance screen.

#### Configuring an Action Taken

Use the following procedure to configure action taken:

1. From the Argus Console, select Code Lists -> Argus -> Action Taken.

2. When the system opens the Code List Maintenance screen, click Action Taken in the Code List in the left pane.

3. The system puts the corresponding data for the selected item in the right pane.

4. Click Add New and enter the E2B code for the new action in the Add New Action Taken section.

5. Click Save.

#### Configuring Age Groups

Use the following procedure to configure age groups:

1. From the Argus Console, select Code Lists -> Argus -> Age Groups.

2. When the system opens the Code List Maintenance screen, locate and click Age Groups in the Code List in the left pane.

3. The system places the corresponding data for the selected item in the right pane.

4. Click Add New and enter the E2B Code for the new age group in the Add New Age Groups section.

5. Click Save.

#### Configuring Age Units

Use the following procedure to configure age units.

1. From the Argus Console, select Code Lists -> Argus -> Age Units.

2. When the system opens the Code List Maintenance screen, click Age Units in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Click Add New and enter the E2B Code for the new age unit in the Add New Age Units section.

5. Click Save.

#### Configuring Attachment Classifications

Use the following procedure to configure attachment classifications:

1. From the Argus Console, select Code Lists -> Argus -> Attachment Classification.

2. When the system opens the Code List Maintenance screen, click Attachment Classification in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Click Add New and click the E2B Additional Doc check box in the Add New Attachment Classification section.

5. Click Save.

#### Configuring Dosage Units

Use the following procedure to configure dosage units:

1. From Argus Console, Code Lists -> Argus -> Dosage Units.

2. When the system opens the Code List Maintenance screen, click Dosage Units in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Select an existing Dosage Unit and enter the new E2B code in the Modify Dosage Units section.

5. Click Save.

#### Configuring an Event Outcome

Use the following procedure to configure an Event Outcome:

1. From the Argus Console, select Code Lists -> Argus -> Event Outcome.

2. When the system opens the Code List Maintenance screen, click Event Outcome in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the new event outcome in the Add New Event Outcome section.

5. Click Save.

#### Configuring Gender

Use the following procedure to configure Gender.

1. From Argus Console, select Code Lists -> Argus -> Gender.

2. When the system opens the Code List Maintenance screen, click Gender in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the gender in the Add New Gender section.

5. Click Save.

#### Configuring Report Type

Use the following procedure to configure Report Type:

1. From the Argus Console, select Code Lists -> Argus -> Report Type.

2. When the system opens the Code List Maintenance screen, click Report Type in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B code for the new report type in the Add New Report Type section.

5. Click Save.

#### Configuring Reporter Type

Use the following procedure to configure Reporter Type:

1. From the Argus Console, select Code Lists -> Argus -> Reporter Type.

2. When the system opens the Code List Maintenance screen, click Reporter Type in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the new reporter type in the Add New Reporter Type section.

5. Click Save.

#### Configuring Routes of Administration

Use the following procedure to configure Routes of Administration:

1. From the Argus Console, select Code Lists -> Argus -> Routes of Administration.

2. When the system opens the Code List Maintenance screen, click Routes of Administration in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the E2B Code for the new route of administration in the Add New Routes of Administration section.

5. Click Save.

#### Configuring a Message Type

Use the following procedure to configure a Message Type:

1. From the Argus Console, select Code Lists -> Argus -> Message Type.

2. When the system opens the Code List Maintenance screen, click Message Type in the Code List in the left pane.

3. The system places the data for the selected item in the right pane.

4. Enter the new message type and other relevant data in the Modify Message Type section.

5. Click Save.

#### E2B Length Check

When you select E2B Length Check, the system generates a report that prints the code list item length check and M2 validation warnings. This menu item has been added under Argus Console -> Tools -> E2B Length Check.

The following table lists the Code List items the length check is run on.

Data Element | LM Field | Argus Field Length | DTD Allowed Length
--- | --- | --- | ---
A.2.1.1d | LM / Clinical Studies / Study Information / Study Description. The application needs to consider the EUDRA-CT length (35) while displaying the message. | 2000 | 100
A.3.1.3b | LM / Regulatory Authorities / Local Company Contact / Title | 40 | 10
A.3.1.4a | LM / Regulatory Authorities / Local Company Contact / Address | 120 | 100
A.3.1.4f | LM / Regulatory Authorities / Local Company Contact / Phone | 20 | 10
A.3.1.4g | LM / Regulatory Authorities / Local Company Contact / Phone / Ext. | 10 | 5
A.3.1.4i | LM / Regulatory Authorities / Local Company Contact / Fax | 50 | 10
A.3.1.4j | LM / Regulatory Authorities / Local Company Contact / Fax / Ext. | 10 | 5
A.3.2.2c | LM / Regulatory Authorities / Agency Information / Contact Information / Title | 40 | 10
A.3.2.2f | LM / Regulatory Authorities / Agency Information / Contact Information / Last Name | 40 | 35
A.3.2.3a | LM / Regulatory Authorities / Agency Information / Contact Information / Address | 120 | 100
A.3.2.3f | LM / Regulatory Authorities / Agency Information / Contact Information / Phone | 20 | 10
A.3.2.3g | LM / Regulatory Authorities / Agency Information / Contact Information / Phone / Ext. | 10 | 5
A.3.2.3i | LM / Regulatory Authorities / Agency Information / Contact Information / Fax | 50 | 10
A.3.2.3j | LM / Regulatory Authorities / Agency Information / Contact Information / Fax / Ext. | 10 | 5
A.2.1.2c | LM / Reporter Information / Address | 120 | 100
B.4.k.2.2 | LM / Products / Key Ingredient | 120 | 100
B.4.k.4.1 | LM / Licenses / License Information / Number | 40 | 35

#### E2B Code Validation

The following table lists the E2B Code Validation items.

Tag Name | DTD Element | Case Form Field | LM Field
--- | --- | --- | ---
primarysourcecountry | A.1.1 | Case Form / General / Reporter Information / Country | LM / Countries / Code (A2)
occurcountry | A.1.2 | Case Form / General / General Information / Country | LM / Countries / Code (A2)
reporttype | A.1.4 | Case Form / General Information / Report Type | LM / Report Type / E2B Code
reportercountry | A.2.1.3 | Case Form / General / Reporter Information / Country | LM / Countries / Code (A2)
qualification | A.2.1.4 | Case Form / General / Reporter Information / Reporter Type | LM / Reporter Type / E2B Code
observestudytype | A.2.3.3 | Case Form / General / Study Information / Observe Study Type | LM / Case Classification / E2B Code
sendertype | A.3.1.1 | LM / Regulatory Authorities / Local Company Contact / Sender Type | LM / Regulatory Authorities / Local Company Contact / Sender Type
sendercountrycode | A.3.1.4e | LM / Regulatory Authorities / Local Company Contact / Country | LM / Countries / Code (A2)
receivertype | A.3.2.1 | LM / Regulatory Authorities / Agency Information / Agency Type | LM / Regulatory Authorities / Agency Information / Agency Type
receivercountrycode | A.3.2.3e | LM / Regulatory Authorities / Agency Information / Contact Information / Country | LM / Countries / Code (A2)
patientonsetageunit | B.1.2.2b | Case Form / Patient / Patient Information / Age Units | LM / Age Units / E2B Code
patientagegroup | B.1.2.3 | Case Form / Patient / Patient Information / Age Group | LM / Age Group / E2B Code
patientsex | B.1.5 | Case Form / Patient / Patient Information / Gender | LM / Gender / E2B Code
parentageunit | B.1.10.2.2b | Case Form / Patient / Parent / Age Unit | LM / Age Units / E2B Code
parentsex | B.1.10.6 | Case Form / Patient / Parent / Gender | LM / Gender / E2B Code
reactionoutcome | B.2.i.8 | Case Form / Events / Event Information / Outcome of Event | LM / Event Outcome / E2B Code
testunit | B.3.1e | Case Form / Patient / Lab Data / Lab Data / Units | LM / Dossage Units / E2B Code
obtaindrugcountry | B.4.k.2.3 | Case Form / Products / Product Information / Obtain Drug Country | LM / Countries / Code (A2)
drugauthorizationcountry | B.4.k.4.2 | LM / Licenses / License Information / Country | LM / Countries / Code (A2)
drugstructuredosageunit | B.4.k.5.2 | Case Form / Products / Dosage Regimens / Dose Units | LM / Dosage Unit / E2B Code
drugcumulativedosageunit | B.4.k.5.7 | Case Form / Products / Total Dose to Primary Event | LM / Dosage Unit / E2B Code
drugadministrationroute | B.4.k.8 | Case Form / Products / Dosage Regimens / Patient Route of Administration | LM / Routes of Administration / E2B Code
drugparadministration | B.4.k.9 | Case Form / Products / Dosage Regimens / Parent Route of Administration | LM / Routes of Administration / E2B Code
drugintervaldosagedefinition | B.4.k.5.5 | LM / Dosage Frequency / Unit | LM / Dosage Frequency / Unit
actiondrug | B.4.k.16 | Case Form / Products / Product Details / Action Taken | LM / Action Taken / E2B Code
mhlwadmicsrcasenumclass | J.4a | Case Form / Analysis / PMDA / General / Report Category | LM / Reporting Category / E2B Code
mhlwadmicsrnewdrugclass | J.8 | Case Form / Analysis / PMDA / Comments / Category of the new drug | LM / License Category / E2B Code
mhlwphaseofstudies | J.12.i.2 | Business Configuration / Studies / Study Development Phase | LM / Study Development Phase / E2B Code